gemcitabine + cisplatin + nivolumab

A combination therapy consisting of gemcitabine, cisplatin, and nivolumab (Opdivo) approved for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. This combination demonstrated significantly improved overall survival and progression-free survival compared to gemcitabine-cisplatin alone in the CheckMate 901 trial. ## Efficacy and Clinical Data The approval was based on the CheckMate 901 trial, a phase 3, open-label, randomized study that demonstrated significant improvements in both overall survival and progression-free survival compared to gemcitabine-cisplatin alone[1][2]. With a median follow-up of approximately 33 months, the combination therapy showed: - Median overall survival of 21.7 months versus 18.9 months with gemcitabine-cisplatin alone (22% reduction in risk of death)[4][6] - Median progression-free survival of 7.9 months versus 7.6 months with gemcitabine-cisplatin alone (28% reduction in risk of disease progression or death)[4][6] - Overall response rate of 57.6% versus 43.1% with gemcitabine-cisplatin alone[3][4] - Complete response rate of 21.7% versus 11.8% with gemcitabine-cisplatin alone[3][6] - Median duration of complete response of 37.1 months versus 13.2 months with gemcitabine-cisplatin alone[5][6] ## Treatment Protocol In the CheckMate 901 trial, patients received: - Nivolumab 360 mg in combination with cisplatin and gemcitabine every 3 weeks for up to 6 cycles - Followed by nivolumab 480 mg monotherapy every 4 weeks for up to 2 years[5][9] ## Safety Profile The safety profile of the combination was consistent with the known profiles of the individual components. Grade 3 or higher adverse events occurred in 61.8% of patients receiving the combination therapy compared to 51.7% in the chemotherapy-alone group[6]. The combination carries warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryofetal toxicity[8]. ## Significance This combination represents a significant advancement as no new agent had previously demonstrated improved survival outcomes when administered concurrently with platinum-based chemotherapies in the first-line treatment of urothelial carcinoma[3][6]. The approval provides a new treatment option for patients with previously untreated metastatic or unresectable urothelial carcinoma.

Brand names

Opdivo + cisplatin + gemcitabine

Other names

GCOpdivo plus GC